Suture system and method

ABSTRACT

A suture system including a suture construct having a first reduction construct configured to be selectively arranged in an expanded state and a reduced state. The first reduction construct includes a first locking limb, a first contractible loop, and a first opposed loop disposed generally opposite to the first contractible loop, wherein reduction of the first opposed loop contracts the first contractible loop from the expanded state into the reduced state and secures the suture construct in the reduced state. The suture construct may also include a second reduction construct. Optionally, the suture system includes a first and a second pusher tube defining a first and a second lumen, respectively, wherein each pusher tubes are advanced over portions of opposed loops, respectively, and wherein distal portions of opposed loops extend beyond the pusher tubes, respectively.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/863,917 (now U.S. Pat. No. 9,492,200), filed Apr. 16, 2013. Theentire disclosure of which is incorporated herein by reference.

FIELD

This disclosure relates to biological medical devices and methods, andparticularly to biological medical suture systems and methods.

BACKGROUND

In many circumstances, it may be desirable to couple two or more bonesor tissue segments together. For example, a bunion (hallux valgus) is acommon deformity characterized by lateral deviation of the great toe(hallux) on the mesophalangeal joint (where the first metatarsal boneand hallux meet). One method of treating this deformity is to pull thegreat toe generally into proper alignment using a suture (or the like)disposed around the adjacent, pointer or index toe. In someapplications, the two ends of the suture may need to be tied together.Additionally, torn or partially ligaments may be treated by suturing theligament portions together. Unfortunately, many surgeons areuncomfortable tying knots because of the possibility of the knotbecoming loose and/or the difficulty associated with tying a knot duringa surgical procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the present invention are set forth bydescription of embodiments consistent with the present invention, whichdescription should be considered in conjunction with the accompanyingdrawings wherein:

FIG. 1 is a plan view of one embodiment of a suture construct consistentwith one embodiment of the present disclosure;

FIG. 2 is a close up of region A in FIG. 1;

FIG. 3 illustrates one embodiment of forming the passageways through thebones consistent with the present disclosure;

FIG. 4 illustrates one embodiment of the suture construct in combinationwith pull strands consistent with the present disclosure;

FIG. 5 illustrates the suture construct disposed within the passagewaysin the bone consistent with at least one embodiment of the presentdisclosure;

FIGS. 6-12 illustrate various embodiments of suture pins consistent withthe present disclosure;

FIG. 13 illustrates one embodiment of the suture construct incombination with one embodiment of a pusher consistent with the presentdisclosure;

FIG. 14 illustrates the suture construct in a locked state consistentwith at least one embodiment of the present disclosure;

FIGS. 15-18 illustrate various steps for forming a suture constructconsistent with at least one embodiment of the present disclosure;

FIG. 19 illustrates another embodiment of suture system;

FIGS. 20 and 21 illustrate installation/reduction steps corresponding tothe suture system illustrated in FIG. 19;

FIG. 22 illustrates another embodiment of the pusher tubes consistentwith the present disclosure;

FIG. 23 illustrates a further embodiment of the pusher tubes consistentwith the present disclosure;

FIGS. 24 and 25 illustrates an embodiment of a suture system incombination with another embodiment of a suture pin for securing twobone fragments;

FIG. 26 illustrates an embodiment of a suture system in combination withthe suture pin of FIGS. 24 and 25 for securing two bones;

FIG. 27 illustrates a bottom perspective view of the suture pin of FIGS.24 and 25;

FIG. 28 illustrates a side view of the suture pin of FIGS. 24 and 25;

FIG. 29 illustrates a bottom view of the suture pin of FIGS. 24 and 25;

FIG. 30 illustrates an end view of the suture pin of FIGS. 24 and 25;

FIG. 31 illustrates a cross-sectional view of one embodiment of a suturepin and a contractible loop extending through an opening in apassageway; and

FIG. 32 illustrates a cross-sectional view of the suture pin of FIGS. 24and 25 and a contractible loop extending through an opening in apassageway.

DETAILED DESCRIPTION

One embodiment of the present disclosure may feature suture systems andmethods for coupling together two bones, bone segments, and/or tissuesegments. The suture systems feature an all suture/thread constructionwhich eliminates the need for the surgeon to tie knots during thesurgical procedure.

By way of a brief overview explained in greater detail herein, oneaspect of the present disclosure features a suture system which may beused for the treatment of hallux valgus (i.e., bunion); however, thesuture system may also be used with other bones and/or may be used forthe treatment of cracked and/or broken bone fragments. The suture systemincludes a suture construct having at least one reduction construct. Thereduction construct includes a locking limb, a contractible loop, and anopposed loop disposed generally opposite to the contractible loop. Thesuture construct is configured to be selectively arranged in an expandedstate/position and a reduced state/position. When in the expandedstate/position, one or more of the contractible loops are passed througha respective passageway from through a first to the second bone or bonefragment until a portion of the contractible loop(s) extends beyond anopening in the second bone or bone fragment. A suture pin may be passedthrough the first (and optionally second contractible loop). Toreduce/tighten the suture construct into the reduced state/position, thelength/size of the opposed loop(s) is reduced thereby reducing thelength/size of the first and second contractible loop(s) and biasing thefirst and second bones/bone fragments towards each other. Once thesuture construct applies a desired amount of force to the bones/bonefragments in the reduced state, tension on the suture construct causesthe opposed loop(s) to reduce against the locking limb(s), therebylocking, fixing, or otherwise securing the suture construct the reducedstate.

With reference to FIG. 1, one embodiment of a suture construct 10 isgenerally illustrated. The suture construct 10 includes one or morereduction constructs (e.g., a first and optionally a second reductionconstruct 28, 30). As explained herein, the first and the secondreduction constructs 28, 30 (which may have the same or differentconfiguration) are configured to be selectively reduced in size andlocked, fixed, or otherwise secured in the reduced formation to apply acompressive force. While the suture construct 10 is illustrated havingtwo reduction constructs 28, 30 separated by a bridge 18, it should beappreciated that a suture construct consistent with the presentdisclosure may include only one reduction construct 28.

The suture construct 10 may be formed from a single piece of suture 12,though it may also be formed from more than one piece of suture 12. Thesuture 12 may include woven and non-woven sutures, either of which maybe formed from one or more threads or fibers. The threads/fibers may allbe the same material or may include two or more different materials. Thesuture 12 may optionally include one or more coatings such as, but notlimited to, antimicrobial materials to reduce potential infection. Thesuture 12 may include absorbable or non-absorbable materials. Thediameter of the suture 12 will depend on the intended application;however, the suture 12 may include, but is not limited to, a #2, #3, #4and/or #5 suture as defined by the United State Pharmacopeia (U.S.P.),for example, a #4 suture.

With additional reference to FIG. 2 (which shows a close-up of region Ain FIG. 1), the suture construct 10 includes the first and secondreduction constructs 28, 30, each separated by a bridge 18. The firstand second reduction constructs 28, 30 each include a first and a secondknot 14, 16. The first and second knots 14, 16 may include any type ofknot which can form a loop 20, 22, respectively. For example, one ormore of the first and second knots 14, 16 may include splice (e.g., asliding splice or the like), a slip knot, a running bowline, etc.Portions of the suture 12 are passed through a respective one of theloops 20, 22 to form the first and second reduction constructs 28, 30.The first and second reduction constructs 28, 30 each include acontractible loop 32, 34 and a opposed loop 36, 38, each of which areseparated by the first and second loops 20, 22, respectively. A firstportion of each of the opposed loops 36, 38 extends through the loops20, 22 from the contractible loops 32, 34, respectively, and a secondportion of each of the opposed loops 36, 38 extends through the loops20, 22 and terminates at the first and second free ends 24, 26 of suture(also referred to as the first and second locking limbs 24, 26). A firstportion of each of the contractible loops 32, 34 extends through theloops 20, 22 from the opposed loops 36, 38, respectively, and a secondportion of each of the contractible loops 32, 34 extends from andterminates at the loops 20, 22.

Optionally, the first and second opposed loops 36, 38 may be temporarilyretained in an expanded position (as generally illustrated in FIGS. 1and 2) using a first and second tab 40, 42, respectively. The tabs 40,42 may include, for example, folded pieces of metal (e.g., but notlimited to, aluminum), plastic, suture, or the like configured to extendthrough the opposed loops 36, 38, thereby preventing the opposed loops36, 38 from being pulled through the first and second loops 20, 22,respectively.

Turning now to FIGS. 3-7, embodiments illustrating how the suture systemcan be used to treat a medical condition are generally illustrated. Withreference to FIG. 3, two generally parallel passageways 44, 45 aredrilled through a first and second bone 46, 47 (e.g., the first andsecond metatarsus bones 46, 47). A drill guide 48 may be used to formthe passageways 44, 45. In particular, the drill guide 48 includes twodrill bushings/openings 50 a, 50 b spaced apart from each other. Thespacing of the bushings 50 a, 50 b is selected based on the size of thebones 46, 47 being drilled. In particular, the spacing may be selectedsuch that the impact on the overall strength of the bones 46, 47 isminimized, thereby reducing the potential of damaging the bones 46, 47.By way of example, the spacing may be selected within the range of 6-10mm. It should also be appreciated that the spacing between the first andsecond splices 14, 16 should generally correspond to the spacing of thebushings 50 a, 50 b.

In practice, the drill guide 48 may be placed against a portion of thesecond bone 47. A first passing pin or drill bit 52 a (e.g., but notlimited to, a 1.2 mm passing pin) is advanced through the first bushing50 a of the drill guide 48 to form a first second portions 44 a, 44 b(collectively referred to as the first passageway 44) in the first andsecond bones 46, 47, respectively. Similarly, a second passing pin ordrill bit 52 b is advanced through the second bushing 50 b of the drillguide 48 to form a first second portions 45 a, 45 b (collectivelyreferred to as the second passageway 45) in the first and second bones46, 47, respectively. The distal ends 53 of the first and second drillbits 52 a, 52 b extend beyond the first bone 46 and the proximal ends 55have not passed through the second bone 47. The first and second drillbits 52 a, 52 b optionally include a loop or snare 54 a, 54 b extendingfrom the proximal ends 55.

With the passageways 44, 45 having been formed, the suture construct 10may then be advanced through the passageways 44, 45. Turning now to FIG.4, the suture construct 10 is illustrated in combination with two pullstrands 56. The pull strands 56 are disposed around a distal end of thefirst and second contractible loops 32, 34 and are configured to bereleasably coupled to the first and second contractible loops 32, 34.For example, the pull strands 56 may include a loop disposed around thefirst and second contractible loops 32, 34. The pull strands 56 may alsobe tied or otherwise releasably secured to the first and secondcontractible loops 32, 34. Optionally, the suture construct 10 includesa suture plate 58. The suture plate 58 includes two apertures 60 spacedapart a distance generally corresponding to the distance between the twopassageways 44, 45 and the spacing of the first and second knots 14, 16.The suture plates 58 may have a “FIG. 8” cross-section or may have agenerally rectangular cross-section.

With reference to FIGS. 3, 4, and 5, the pull strands 56 are configuredto be coupled to the loops/snares 54 a, 54 b extending from the drillbits 52 a, 52 b. The drill bits 52 a, 52 b are then retracted throughthe passageways 44, 45, thereby advancing the pull strands 56 throughthe passageways 44, 45. Once the pull strands 56 are beyond the firstbone 46, the pull strands 56 can be used to pull/advance a portion ofthe contractible loops 32, 34 through a respective one of thepassageways 44, 45 (from the second bone 47 and then through the firstbone 46) until a distal portion of the contractible loops 32, 34 extendsbeyond the first bone 46. The contractible loops 32, 34 may be advancedthrough the passageways 44, 45 until the bridge 18 (or the optionalsuture plate 58) is proximate to or abuts against the second bone 47,thereafter the pull strands 56 may be disconnected/released from thefirst and second contractible loop 32, 34 as generally illustrated inFIG. 5.

With the first and second contractible loops 32, 34 advanced through thepassageways 44, 45, the suture pin 62 (FIG. 5) is then coupled to thefirst and second contractible loop 32, 34 such that the suture construct10 forms an enclosed loop extending around a portion of the first andsecond bones 46, 47. The enclosed loop suture construct is defined bythe first and second contractible loops 32, 34, the bridge 18, and thesuture pin 62. According to one embodiment, the suture pin 62 is passedthrough the first and second contractible loops 32, 34 such that aportion of the first and second contractible loops 32, 34 is disposedaround a portion of the suture pin 62. Alternatively (or in addition),the suture pin 62 may be secured to the first and second contractibleloops 32, 34 using one or more fasteners, clamps, or the like.

The suture pin 62 may have a length larger than the spacing between thetwo passageways 44, 45 in the first bone 46. Having the length of thesuture pin 62 greater than the spacing between the two passageways 44,45 in the first bone 46 allows the first and second contractible loops32, 34 to extend substantially parallel to the two passageways 44, 45,thereby minimizing stress placed on the bones 46, 47 by the first andsecond contractible loops 32, 34. For example, if the first and secondcontractible loops 32, 34 are not parallel to the passageways 44, 45,then the first and second contractible loops 32, 34 will exert a forceagainst the sideways of the passageways 44, 45 and/or the portion ofbone between the passageways 44, 45, causing the first and secondcontractible loops 32, 34 to dig into and damage the bones 46, 47.

In addition to having a length greater than the spacing between the twopassageways 44, 45 in the first bone 46, the suture pin 62 may also havean overall width, diameter, or cross-section that is greater than thediameter of the passageways 44, 45 such that the suture pin 62 will notfit within the passageways 44, 45. As explained herein, the suture pin62 consistent with the present disclosure may be coupled to the firstand second contractible loops 32, 34 after the first and secondcontractible loops 32, 34 have been advanced through the passageways 44,45. As a result, the suture pin 62 does not need to be advanced throughthe passageways 44, 45 and diameter of the passageways 44, 45 may beminimized (i.e., the diameter of the passageways 44, 45 need only beslightly larger than the overall cross-section of the first and secondcontractible loops 32, 34). As may be appreciated, the smaller diameterof the passageways 44, 45 minimizes the negative impact on the strengthof the bones 46, 47 by reducing the amount of bone material that isremoved.

Turning now to FIGS. 6-12, various embodiments of the suture pin 62 aregenerally illustrated. For example, FIG. 6 generally illustrates asuture pin 62 a having a generally elongated shape. The suture pin 62 amay be formed from metal (e.g., but not limited to, stainless steel,titanium, aluminum, chromium cobalt, and/or any alloy thereof), plastic(e.g., but not limited to, polyether ether ketone (PEEK), polyethylene(PE) such as ultrahigh molecular weight polyethylene (UHMWPE) and highdensity polyethylene (HDPE), or the like), composite materials (e.g.,reinforced plastics such as fiber-reinforced polymers, metal composites,ceramic composites, or the like), sutures (woven and/or non-wovensuture), or the like. The suture pin 62 a may have a generallyconsistent cross-section throughout its length. The suture pin 62 a mayhave a generally circular cross-section and/or may have a non-circularcross-section (e.g., rectangular, oval, or the like).

With reference to FIG. 7, a suture pin 62 b is illustrated having a mainbody 64, an end region 66, and at least one reduced portion 68 having asmaller cross-section compared to the main body 64 and/or the end region66. The reduced portion 68 may include a groove, slot, channel, or thelike configured to aid in locating the first and second contractibleloops 32, 34 with respect to the suture pin 66 b, and aid in preventingthe suture pin 62 b from becoming dislodged with respect to the firstand second contractible loops 32, 34 (i.e., aid in securing the firstand second contractible loops 32, 34 with respect to the reduced portion68). The reduced portions 68 may extend radially around only a portionof the suture pin 62 b (e.g., 180 degrees around, 90 degrees around, orthe like) or may extend radially around the entire cross-section of thesuture pin 62 b. The positions of the reduced portions 68 may beseparated from each other a distance generally corresponding to thedistance between the two passageways 44, 45 and the spacing of the firstand second splices 14, 16. While the suture pin 62 b is illustratedhaving two reduced portions 68, it should be appreciated that the suturepin 62 b may include only one or may include more than two reducedportions 68 which are distributed along the length of the suture pin 62b. Having more than two reduced portions 68 may allow the suture pin 62b to be used to different suture constructs 10 having different spacingbetween the first and second splices 14, 16.

As generally illustrated in FIGS. 8-12, a suture pin 62 consistent withthe present disclosure may also include one or more enlarged portionsconfigured to aid in locating the first and second contractible loops32, 34 with respect to the suture pin 66, and aid in preventing thesuture pin 62 from becoming dislodged with respect to the first andsecond contractible loops 32, 34 (i.e., aid in securing the first andsecond contractible loops 32, 34 with respect to the enlarged portions).The enlarged portions may be separated from each other a distance whichis generally equal to or greater than the distance between the twopassageways 44, 45 and the spacing of the first and second splices 14,16.

One embodiment of a suture pin 62 c having an enlarged portion isgenerally illustrated in FIG. 8. More specifically, the suture pin 62 cis formed from one or more pieces of suture (either woven or non-wovensuture). The suture pin 62 c includes enlarged portions 70 disposed atgenerally opposite end regions of a main body 64. The enlarged portions70 have a cross-section that is larger than the cross-section of themain body 64. The overall width, diameter, or cross-section of theenlarged portions 70 may also be greater than the diameter of thepassageways 44, 45 such that the suture pin 62 c will not fit within thepassageways 44, 45.

The enlarged portions 70 may be formed by forming one or more knots(such as, but not limited to, an overhand knot, half hitch knot, squareknot, half knot, or the like). The knots may be made from the same pieceof suture as the main body 64, and/or may include additional pieces ofsuture. A benefit to a suture pin having an all-suture construction isthat is minimizes the amount of different materials used by the suturesystem. Additionally, tissue may grow into the suture material, therebyreducing the possibility of the suture pin 62 c from migrating withrespect to the first and second contractible loops 32, 34.

Another embodiment of a suture pin 62 d having enlarged portions 70 isgenerally illustrated in FIG. 9. The suture pin 62 d may be similar tothe suture pin 62 c, however, the suture pin 62 d includes a rigidelement/member 72 over which the suture 74 is woven, tied, or otherwisesecured around. For example, the rigid element 72 may include anelongated member (e.g., a pin or the like as generally described inFIGS. 6, 7, and 10-12). The combination of the rigid element 72 and thesuture element 74 may increase the structural rigidity of the suture pin62 d, thereby facilitating the assembly of the suture system during thesurgical procedure. Additionally, the combination of the rigid element72 and the suture element 74 may increase the overall strength of thesuture pin 62 d, and may also allow for tissue growth into the sutureelement 74 as discussed herein.

Other embodiments of a suture pin 62 e-62 g having enlarged portions 70are generally illustrated in FIGS. 10-12. The suture pins 62 e-62 ginclude a generally elongated main body 64 having enlarged portions 70disposed about the proximal end regions. The main body 64 and theenlarged portions 70 may be formed as an integral component (e.g.,pieces bonded together, which may be made from the same or differentmaterials) or may be formed as a unitary component (i.e., formed as asingle component from the same material). The suture pins 62 e-62 g maybe formed from metal (e.g., but not limited to, stainless steel,titanium, aluminum, chromium cobalt, and/or any alloy thereof), plastic(e.g., but not limited to, polyether ether ketone (PEEK), polyethylene(PE) such as ultrahigh molecular weight polyethylene (UHMWPE) and highdensity polyethylene (HDPE), or the like), or composite materials (e.g.,reinforced plastics such as fiber-reinforced polymers, metal composites,ceramic composites, or the like).

The enlarged portions 70 may have a generally “T” shaped or disc-shapedprotrusion extending generally radially outward as generally illustratedin FIG. 10 or a may have a generally “L” shaped protrusion extendinggenerally radially outward as generally illustrated in FIG. 11. Whilethe protrusions are illustrated extending radially outward atapproximately 90 degrees from the body portion 64, it should beappreciated that the protrusions may extend radially outwardly at anangle A from the body portion 64 in the range of 10 degrees to 170degrees. Additionally, while the protrusions are illustrated having agenerally planar or linear shape, it should be understood that theprotrusions may have a non-linear or non-planar shape such as a curvedor arcuate shape. The enlarged portions 70 may also have a generallycircular or cross-section, spherical shape, and/or may have anon-circular cross-section (e.g., rectangular, oval, or the like) asgenerally illustrated in FIG. 12.

Turning back to FIG. 5, with the suture pin 62 extending between thefirst and second contractible loops 32, 34, the first and secondcontractible loops 32, 34 may be pulled away from the first bone 46 tourge the suture pin 62 against the first bone 46, thereby aiding inmaintaining the suture pin 62 within the first and second contractibleloops 32, 34. The first and second tabs 40, 42 are removed from thefirst and second opposed loops 36, 38 and a pusher 76 is advancedthrough the first and second opposed loops 36, 38 as generallyillustrated in FIG. 13.

The pusher 76 is configured to aid in reducing/tightening the suturesystem and to urge the first and second bones 46, 47 towards each other.According to one embodiment, the pusher 76 includes a pivoting section78 which is advanced through the first and second opposed loops 36, 38and a pull snare 77 extending outward beyond the distal end 79 of thepivoting section 78. The pivoting section 78 optionally extends at anangle from an arm section 80. While the angle between the pivotingsection 78 and the arm section 80 is illustrated at approximately 90degrees, it should be appreciated that the angle therebetween willdepend on the application and the surgeon's preference and may, forexample, be in the range of 45 to 135 degrees. The pusher 76 alsooptionally includes a handle portion 82 coupled to the arm section 80 toaid in gripping the pusher 76.

To reduce/tighten the suture system, the surgeon pulls the locking limbs24, 26 of the suture construct 10 away from the second bone 47 whilesimultaneously urging the pusher 76 towards the second bone 47, therebyreducing the length of the first and second contractible loops 32, 34and applying a compressive force through the first and secondcontractible loops 32, 34, the bridge 18 (and the optional suture plate58), and suture pin 62 to bias the first and second bones 46, 47 towardseach other. More specifically, the length of the locking limbs 24, 26 ofthe suture construct 10 is extended as a portion of the suture 12 ispulled from the first and second contractible loops 32, 34 and throughthe opposed loops 36, 38. The pusher 76 prevents the opposed loops 36,38 from self-collapsing as the locking limbs 24, 26 are pulled andeffectively acts as a pulley.

Once the suture system applies a desired amount of force to urge thefirst and second bones 46, 47 towards each other, the locking limbs 24,26 of the suture construct 10 are advanced into and captured by the pullsnare 77 extending out from the distal end 79 of the pusher 76. Thepusher 76 is then retracted through the first and second opposed loops36, 38, causing a least a portion of the locking limbs 24, 26 to passthrough the opposed loops 36, 38 as generally illustrated in FIG. 14.The tension on the suture construct 10 causes the opposed loops 36, 38to reduce against the locking limbs 24, 26, thereby locking the sutureconstruct 10 and preventing the suture construct 10 from loosening. Oncethe suture construct 10 is locked, excess lengths of the locking limbs24, 26 may be trimmed proximate to the opposed loops 36, 38.

Turning now to FIGS. 15-18, the steps for forming one embodiment of asuture construct 10 consistent with one embodiment of the presentdisclosure is generally illustrated. With reference to FIG. 15, a lengthof suture 12 is provided and the spacing between the first and secondknots 14, 16 is determined based on the desired spacing between thefirst and second passageways 44, 45. Turning now to FIG. 16, the firstand second knots 14, 16 are formed in the suture 12 (for example, butnot limited to, using any splicing technique known to those skilled inthe art) and are separated by the bridge 18. The first and second loops20, 22 are also formed as a result of forming the first and second knots14, 16, respectively. Intermediate portions 84, 86, FIG. 17, of thesuture 12 are then passed through the first and second loops 20, 22 toform the first and second contractible loops 32, 34 and the first andsecond opposed loops 36, 38 as generally illustrated in FIG. 18.

With reference to FIG. 19, another embodiment of a suture system 1 a isgenerally illustrated. The suture system 1 a includes a suture construct10 a, a first and a second pusher tubes 100(1), 100(2), a suture pin 62(not shown for clarity), and optionally a suture plate 58 (also notshown for clarity). The suture construct 10 a is similar to the sutureconstruct 10 described herein, except that the first and second opposedloops 36, 38 have been lengthened, the locking limbs 24, 26 of thesuture 12 have been advanced through the opposed loops 36, 38, and thelumens 101(1), 101(2) of the pusher tubes 100(1), 100(2) have beenadvanced over a portion of the opposed loops 36, 38 such that a distalportion 102(1), 102(2) of the opposed loops 36, 38 extends beyond adistal end 104(1), 104(2) of the pusher tubes 100(1), 100(2). Theproximal ends 106(1), 106(2) of the pusher tubes 100(1), 100(2) areproximate to and/or abuts against the splice snares 20, 22 and/or thesplices 14, 16, respectively. Optionally, the “hot side” 108(1), 108(2)of the opposed loops 36, 38 may be marked, for example, using one ormore marking indicia, tabs 110 or the like. As used herein, the term“hot sides” of the opposed loops 36, 38 refers to the portions of theopposed loops 36, 38 which pass through the first and second loops 20,22 from the first and second contractible loops 32, 34 when the firstand second contractible loops 32, 34 are reduced in size.

The suture construct 10 a of the system 1 a is installed in the firstand second bones 46, 47 in a manner similar to the suture construct 10.For the sake of brevity, all of the installation steps of the suturesystem 1 a have not been repeated, and reference is made to theremainder of the instant application. Specifically, the passageways 44,45 may be formed in the bones 46, 47 and the contractible loops 32, 34are advanced through a respective one of the passageways 44, 45 (fromthe second bone 47 and then through the first bone 46) until a distalportion of the contractible loops 32, 34 extends beyond the first bone46 in the same manner as described herein. The contractible loops 32, 34may be advanced through the passageways 44, 45 until the bridge 18 (orthe optional suture plate 58) is proximate to or abuts against thesecond bone 47. With the first and second contractible loops 32, 34advanced through the passageways 44, 45, a suture pin 62 is then coupledto the first and second contractible loops 32, 34 such that the sutureconstruct 10 forms an enclosed loop extending around a portion of thefirst and second bones 46, 47 in the same manner described herein. Withthe suture pin 62 extending between the first and second contractibleloops 32, 34, the first and second contractible loops 32, 34 may bepulled away from the first bone 46 to urge the suture pin 62 against thefirst bone 46, thereby aiding in maintaining the suture pin 62 withinthe first and second contractible loops 32, 34.

Whereas the reduction of the suture construct 10 utilized a pusher 76,the installation and reduction of the suture construct 10 a replaces thepusher 76 and utilizes one or more pusher tubes 100(1), 100(2) instead.More specifically, with the suture pin 62 extending between the firstand second contractible loops 32, 34 and urged against the first bone46, the user grasps the hot sides 108(1), 108(2) (for example, using agripper, grasper, forceps, 112 or the like as generally illustrated inFIG. 20) of the opposed loops 36, 38 and pulls the hot sides hot sides108(1), 108(2) through the pusher tubes 100(1), 100(2) and distally oraway from the contractible loops 32, 34 (for example, but not limitedto, rotating or twisting the forceps 112 against a distal end 104(1),104(2) of the pusher tubes 100(1), 100(2) as generally illustrated inFIG. 21). The pusher tubes 100(1), 100(2) may have a length sufficientto allow the surgeon to operate on the distal ends 104(1), 104(2)outside of the patient's tissue.

As may be appreciated, pulling the hot sides 108(1), 108(2) of theopposed loops 36, 38 causes the length of the contractible loops 32, 34to be reduced since the hot sides 108(1), 108(2) are slidably coupled tothe contractible loops 32, 34 through the loops 20, 22. Reducing thelengths of the opposed loops 36, 38 applies a compressive force throughthe first and second contractible loops 32, 34, the bridge 18 (and theoptional suture plate 58), and suture pin 62 to bias the first andsecond bones 46, 47 towards each other. Once the desired amount ofcompressive force is applied to the bones 46, 47, the suture construct10 a may be temporally maintained in the compressed state by urging thepusher tubes 100(1), 100(2) against the loops 20, 22 and/or the knots14, 16, and the tension on the hot sides 108(1), 108(2) (e.g., by meansof the forceps 112) may be temporarily eliminated. While urging thepusher tubes 100(1), 100(2) against the loops 20, 22 and/or the knots14, 16, the user may then pull on the locking limbs 24, 26 of the sutureconstruct 10 a. As noted above, the locking limbs 24, 26 are alreadypassed through the opposed loops 36, 38. As the user pulls on thelocking limbs 24, 26, the length of the opposed loops 36, 38 decreasesuntil the opposed loops 36, 38 are compressed against the locking limbs24, 26 extending therethrough. The tension on the suture construct 10 acauses the opposed loops 36, 38 to reduce against the locking limbs 24,26, thereby locking the suture construct 10 a and preventing the sutureconstruct 10 a from loosening. Once the suture construct 10 a is locked,excess lengths of the locking limbs 24, 26 may be trimmed proximate tothe opposed loops 36, 38.

The pusher tubes 100(1), 100(2) optionally include one or moreoutriggers 114 extending generally outward from the distal ends 104(1),104(2) of the pusher tubes 100(1), 100(2), for example, outwardly fromthe longitudinal axis of the pusher tubes 100(1), 100(2) as generallyillustrated in FIG. 21. The outriggers 114 may facilitate pulling thehot sides 108(1), 108(2) of the opposed loops 36, 38 through the pushertubes 100(1), 100(2). More specifically, the outrigger 114 is configuredto provide an increased area against which the forceps or other grasper112 may contact against.

With reference to FIG. 22, the pusher tubes 100(1), 100(2) may include aplurality of outriggers 114(1)-114(n) extending generally outwardly fromthe distal ends 104(1), 104(2) of the pusher tubes 100(1), 100(2). Forexample, the pusher tubes 100(1), 100(2) may include a first and asecond outrigger 114(1), 114(n) which extend outward from generallyopposite sides of the pusher tubes 100(1), 100(2), e.g., the first andsecond outriggers 114(1), 114(2) to form a cradle-like structureconfigured to reduce and/or prevent the forceps/graspers 112 fromslipping off the distal ends 104(1), 104(2) of the pusher tubes 100(1),100(2) as the forceps/graspers 112 are rotated or twisted. For example,the first and second outriggers 114(1), 114(2) may be disposedapproximately 180 degrees from each other. It should be appreciated,however, that the first and second outriggers 114(1), 114(2) may bedisposed at any other angle relative to each other to form a crook. Forexample, the first and second outriggers 114(1), 114(2) may be disposedat an angle less than 180 degrees relative to each other, for example,an obtuse angle as generally illustrated in FIG. 23.

Optionally, one or more of the proximal ends 160(1), 106(2) of thepusher tubes 100(1), 100(2) may include a taper 116 to aid invisualization of the tip. Additionally, the pusher tubes 100(1), 100(2)may optionally include one or more apertures 118. The apertures 118 mayfacilitate sterilization of the pusher tubes 100(1), 100(2) by allowingthe sterilization medium to more easily flow through the lumens 101(1),101(2) of the pusher tubes 100(1), 100(2) and/or may facilitate moldingof the pusher tubes 100(1), 100(2) by allowing pins to be alignedthrough the apertures 118 to aid in aligning a centering pins disposedthrough the lumens 101(1), 101(2).

The pusher tubes 100(1), 100(2) facilitate the reduction of the sutureconstruct 10 a. In particular, the pusher tubes 100(1), 100(2) allow theuser to pull the suture 12 (e.g., the hot sides 108(1), 108(2)) from theopposed loops 36, 38 linearly through the first and second loops 20, 22,thereby allowing a user to more easily apply a much greater amount ofcompressive force through the suture system 1 a. Moreover,rotating/twisting the hot sides 108(1), 108(2) using the forceps 112 onthe distal ends 104(1), 104(2) of the pusher tubes 100(1), 100(2)creates a mechanical advantage (e.g., a pulley-like effect) whichgreatly increases the amount of compressive force which may be appliedthrough the suture system 1 a.

Turning now to FIGS. 24-30, another embodiment of a suture pin 62 h isgenerally illustrated. In particular, FIGS. 24 and 25 generallyillustrate one embodiment of a suture construct 10 a in combination withthe suture pin 62 h for securing two bone fragments 125 a, 125 b. FIG.26 generally illustrates one embodiment of a suture construct 10 a incombination with the suture pin 62 h for securing two bones 46, 47.FIGS. 27-30 generally illustrate various views of the suture pin 62 h.As will described in more detail herein, the suture pin 62 h reduces theamount of friction and/or force required to reduce the suture construct,thereby providing a greater tactile feel to the surgeon, minimizingpotential damage to the bones/bone fragments, and/or providingsufficient strength/rigidity to the suture pin to prevent damage/failureof the suture pin while reducing the suture construct.

As may be appreciated, the main body of the suture pin should be strongenough to prevent failure when reducing the suture construct. Putanother way, if the suture pin is not strong enough, then the forcesexerted against the suture pin by the suture construct will excessivelybend the suture pin causing an unacceptable amount of deformation of thesuture pin which can lead to bone damage or failure of the suture pin.As the cross-sectional thickness of the suture pin is increased,however, the main body of the suture pin begins to close/cover-over theopening in the bone defined by the passageway therethrough. An exampleof this is illustrated in FIG. 31. In particular, a cross-section of asuture pin 62 and the opening 120 of passageway 44 in the bone 46 isgenerally illustrated. The suture pin 62 includes a rectangular mainbody 64 over which the contractible loop 32 slides. Because thecross-sectional thickness of the main body 64 (i.e., the portion of thesuture pin which extends across the opening 120) is larger than thediameter of the opening 120 to provide sufficient strength to the suturepin 62, the main body 64 will cover or block the opening 120. As themain body 64 blocks the opening 120, the contractible loop 32 is forcedto travel between the main body 64 and the opening 120 and/or thecontractible loop 32 is forced to cut a groove into the bone 46 in thearea proximate to the opening 120 when the suture construct is reduced.Consequently, the suture pin 62 significantly increases thefriction/resistance and reduces the tactile feel when reducing thesuture construct.

In addition, the rectangular cross-section of the main body 64significantly increases the amount of friction when reducing the sutureconstruct. In particular, because the contractible loop 32 is forced totravel between the main body 64 and the opening 120, the contractibleloop 32 must slide across the four corners 122 a, 122 b, 122 c 122 d ofthe main body 64 as well as two portion portions 124 a, 124 b of theperimeter of the opening 120. The four corners 122 a, 122 b, 122 c 122 dand portions 124 a, 124 b generate a very high stress and/or frictionconcentrations, thereby increasing the overall amount of force necessaryto slide the contractible loop 32 when reducing the suture construct.

Referring back to FIGS. 24-30, the suture pin 62 h is configured tominimize and/or eliminate the above described issues. In particular, thesuture pin 62 h includes a main body 64 having a generally circularcross-section extending between a first and a second enlarged portion70. The main body 64 may include a length which is greater than thespacing of the bridge 18 to compensate for non-parallel passageways 44,45. For example, for a bridge having a length of 10 mm, the main body 64may include a length of 17 mm to 20 mm. The diameter of the main body 64should be selected to prevent an undesirable amount of deformationand/or failure of the suture pin 62 h based on the intended use of thesuture construct. By way of an example, a suture pin 62 h constructedfrom a titanium alloy used with a suture construct having a #4 suture totreat hallux valgus may include a main body 64 having a diameter ofapproximately 1 mm (which may be approximately equal to the diameter ofthe passageway 44). It should be appreciated, thought, that this is justan example, and that the diameter of the main body 64 of the suture pin62 h will depend on the intended application as well as the intendedforces exerted by the suture system during reduction.

With reference to FIG. 32, a cross-section of the main body 64 of thesuture pin 62 h is illustrated along with the contractible loop 32extending through the opening 120 of the passageway 44. Depending on thediameter of the main body 64, the suture pin 62 h may eliminate thefriction points (e.g., when the diameter of the main body 64 is lessthan the diameter of the opening 120 of the passageway 44) or may haveonly two friction points 104 a, 124 b which correspond to the locationswhere the contractible loop 32 passes between the main body 64 and theopening 120 (e.g., when the diameter of the main body 64 is equal to orgreater than the diameter of the opening 120 of the passageway 44). Thegenerally circular cross-section of the main body 64 acts as a pulley,thereby allowing the contractible loop 32 to slide smoothly around aportion of the perimeter of the main body 64 (e.g., greater than orequal to 180 degrees around the main body 64) as the contractible loop32 is reduced. As a result, the suture pin 62 h with a main body 64having a generally circular cross-section reduces the amount of frictionand/or force required to reduce the suture construct. Additionally, thereduction in friction points allows the suture pin 62 h to provide agreater tactile feel to the surgeon and minimizes potential damage tothe bones/bone fragments. Moreover, the overall strength of the suturepin 62 h may be increased while preventing/minimizing the suture pin 62h from covering/blocking the opening 120 of the passageway 44.

With reference again to FIGS. 24-30, the enlarged portions 70 of thesuture pin 62 h may include a bone facing surface 126 having a generallyconcaved contour. The concaved contour is configured to allow the bonefacing surface 126 to generally conform to the bone surface, e.g., toallow the bone facing surface 126 to sit generally congruent with thebone face. The concaved bone facing surface 126 helps distribute theforces exerted by the suture system more evenly across the bone 46 andalso helps position the suture pin 62 h during assembly/implanting ofthe suture system within passageway(s) 44, 45.

One or more of the enlarged portions 70 of the suture pin 62 h may alsofeature one or more shoulders 127 extending outwardly beyond the mainbody 64. For example, the shoulders 127 may form a generally anarrowhead-like shape which extend outward and generally towards theopposite end (though the shoulders 127 may extend outward generallyperpendicularly from the main body 64 or outward generally away from theopposite end). As discussed herein, the enlarged portions 70 may aid inkeeping the contractible loop(s) 32, 34 disposed on the main body 64during assembly/implanting of the suture system within passageway(s) 44,45.

While the main body 64 is described having a generally circularcross-section, it may be appreciated that the main body 64 may alsoinclude a generally oval cross-section. Additionally, while the entiremain body 64 is illustrated having a generally circular, it may beappreciated that only the portions or regions of the main body 64 overwhich the contractible loop(s) 28, 30 slide when reducing the sutureconstruct may have a generally circular or oval cross-section. Moreover,while the suture pin 62 h is illustrated having a first and a secondenlarged portion 70, it may be appreciated that the main body 64 mayextend between one or more reduced portions as disclosed herein.

Variations of the suture system and suture construct described hereinare considered to be part of this disclosure. For example, while thesuture construct the suture construct described above is generallysymmetrical about the bridge (e.g., the suture construct is illustratedhaving first and second knots, first and second loops, first and secondcontractible loops, and first and second opposed loops separated by thebridge), the bridge section may be eliminated and the suture constructmay feature only one half of the remaining construct (i.e., a singlereduction construct). More specifically, the suture construct mayalternatively include only one knot, one loop, one contractible loop,and one opposed loop. The contractible loop may be passed through asingle passageway formed through the first and second bones. A firstsuture pin may be disposed through a distal end of the contractible loopagainst the first bone and a second splice pin may be disposed through aproximal end of the contractible loop against the second bone. Thesuture construct may then be tightened by pulling on the locking limb ofthe suture using a pusher or pusher tube as generally described herein.Once the desired amount of force is applied by the suture construct, thetension on the suture construct causes the opposed loop to reduceagainst the locking limb, thereby locking the suture construct andpreventing the suture construct from loosening. Once the sutureconstruct is locked, the locking limb may be trimmed proximate to theopposed loop.

One or more of the suture systems consistent with the present disclosureprovide numerous advantages. For example, the suture systems may includean all thread (suture) repair device which does not require the surgeonto tie any knots, welds, or the like in order to secure and/or draw thesuture system tight. The elimination of knots is significant becausemany surgeons are uncomfortable tying knots due to the possibility ofthe knot becoming loose and/or the difficulty associated with tying aknot during a surgical procedure. Additionally, welding increases thepossibility of accidental collateral damage to surrounding tissue andmay be difficult during a surgical procedure.

Additionally, the suture systems consistent with the present disclosureeliminate the need to pass buttons, pledgets, or the like throughpassageways formed in the bone. As a result, the passageways formed inthe bone may have a smaller diameter and may minimize the potential ofcausing incidental complications (such as, but not limited to, damagingthe bones during drilling and/or cracking the bones after installation).

The suture systems consistent with the present disclosure also providean “equilibrium” construct. More specifically, the suture systemsconsistent with the present disclosure distribute the compressive forcegenerated by the suture system evenly across the entire suture system.In contrast, other suture systems utilize two separate and distinctsutures. Consequently, one suture may exert more compressive force thanthe other suture. This uneven compressive force may place additionalstress on the tissue and/or bones, and may lead to the tissue or bonesfailing.

According to one aspect, the present disclosure features a suture systemincluding a suture construct having a first reduction constructconfigured to be selectively arranged in an expanded state and a reducedstate. The first reduction construct includes a first locking limb, afirst contractible loop, and a first opposed loop disposed generallyopposite to the first contractible loop, wherein reduction of the firstopposed loop contracts the first contractible loop from the expandedstate into the reduced state and secures the suture construct in thereduced state. The suture construct may also include a second reductionconstruct.

According to another aspect, the present disclosure features a suturesystem including a first and a second reduction construct separated by abridge. Each of the reduction constructs features a knot defining aloop, a contractible loop and an opposed loop separated by the loop, anda locking limb extending from the loop and the opposed loop. Each of thereduction constructs is configured to be selectively reduced from anexpanded state to a reduced state by reducing a length of thecontractible loop by urging the locking limb through the loop from theopposed loop, thereby advancing a portion of the contractible loopthrough the loop and into the opposed loop.

According to yet another aspect, the present disclosure features asuture system including a first and a second reduction constructseparated by a bridge. Each of the reduction constructs is configured tobe selectively arranged in an expanded state and a reduced state andeach includes a locking limb, a contractible loop, and an opposed loopdisposed generally opposite to the contractible loop. Reduction of theopposed loop contracts the contractible loop from the expanded stateinto the reduced state and secures the suture construct in the reducedstate.

According to yet a further aspect, the present disclosure features asuture pin including a first and a second enlarged portion and anelongated body portion extending between the first and the secondenlarged portion. The elongated body portion has a generally circularcross-section. The first and the second enlarged portion have across-section which greater than a cross-section of the elongated bodyportion.

According to another aspect, the present disclosure features a methodfor securing two bones together using a suture system. The methodincludes forming a first and a second passageway, each extending througha first and a second bone; advancing a distal portion of a first and asecond contractible loop through a respective one of the first and thesecond passageways until the distal ends extend beyond the first bone,wherein proximal regions of the first and the second contractible loopsare separated by a bridge, the bridge being disposed proximate to thesecond bone; advancing a suture plate through the distal portion of thefirst and the second contractible loops extending beyond the first bone;and reducing the first and the second contractible loops disposed withinthe first and the second passageways by advancing a first and a secondlocking limb from a first and a second opposed loop and through a firstand a second loop, respectively, thereby advancing portions of the firstand second contractible loops through the first and the second loops andinto the first ands second opposed loops.

According to yet a further aspect, the present disclosure features amethod for forming a suture construct. The method includes providing alength of suture; forming a first and a second knot and a first and asecond loop, respectively, in the suture, the first and second knotsbeing separated by a bridge; and passing intermediate portions of thesuture through the first and the second loops to form a first and asecond contractible loop and a first and a second opposed loop,respectively, wherein a first and a second locking limb extends from thefirst and the second opposed loops through the first and the secondloops, respectively.

It should be appreciated that various features of the differentembodiments described herein may be combined together.

While the principles of the present disclosure have been describedherein, it is to be understood by those skilled in the art that thisdescription is made only by way of example and not as a limitation as tothe scope of the invention. The features and aspects described withreference to particular embodiments disclosed herein are susceptible tocombination and/or application with various other embodiments describedherein. Such combinations and/or applications of such described featuresand aspects to such other embodiments are contemplated herein. Otherembodiments are contemplated within the scope of the present inventionin addition to the exemplary embodiments shown and described herein.Modifications and substitutions by one of ordinary skill in the art areconsidered to be within the scope of the present invention, which is notto be limited except by the following claims.

All definitions, as defined and used herein, should be understood tocontrol over dictionary definitions, definitions in documentsincorporated by reference, and/or ordinary meanings of the definedterms.

The indefinite articles “a” and “an,” as used herein in thespecification and in the claims, unless clearly indicated to thecontrary, should be understood to mean “at least one.”

The phrase “and/or,” as used herein in the specification and in theclaims, should be understood to mean “either or both” of the elements soconjoined, i.e., elements that are conjunctively present in some casesand disjunctively present in other cases. Other elements may optionallybe present other than the elements specifically identified by the“and/or” clause, whether related or unrelated to those elementsspecifically identified, unless clearly indicated to the contrary.

All references, patents and patent applications and publications thatare cited or referred to in this application are incorporated in theirentirety herein by reference.

Additional disclosure in the format of claims is set forth below:

What is claimed is:
 1. A suture system comprising: a suture constructincluding a first reduction construct configured to be selectivelyarranged in an expanded state and a reduced state, said first reductionconstruct comprising: a first locking limb; a first contractible loop;and a first opposed loop disposed generally opposite to said firstcontractible loop, wherein reduction of said first opposed loopcontracts said first contractible loop from said expanded state intosaid reduced state and secures said suture construct in said reducedstate; a suture pin configured to be disposed through said firstcontractible loop, wherein said suture pin includes an elongated mainbody having a generally circular cross-section extending between a firstand a second enlarged portion, said first and said second enlargeportions extending outwardly from said elongated main body; and a firstpusher tube defining a first lumen, wherein the first pusher tube isadvanced over portions of said first opposed loop, and wherein a distalportion of the first opposed loop extend beyond the first pusher tube.2. The suture system of claim 1, wherein said first and said secondenlarged portions include a generally concaved bone facing surface. 3.The suture system of claim 1, wherein said first contractible loop andsaid first opposed loop are separated by a first loop defined by a firstknot.
 4. The suture system of claim 3, wherein a first portion of saidfirst opposed loop extends through said first loop from said firstcontractible loop, and wherein a second portion of said first opposedloop extends through said first loop and terminates at said firstlocking limb.
 5. The suture system of claim 4, wherein a first portionof said first contractible loop extends through said first loop fromsaid first opposed loop, and wherein a second portion of said firstcontractible loop extends from and terminates at said first knot.
 6. Thesuture system of claim 3, wherein a length of said first contractibleloop is reduced by pulling said locking limb, causing a portion of saidsuture to pass from said first contractible loop and through said firstknot, and through said first opposed loop.
 7. The suture system of claim3, wherein said first locking limb is configured to be disposed throughsaid first opposed loop to lock said suture construct.
 8. The suturesystem of claim 1, further comprising a second reduction constructseparated from said first reduction construct by a bridge, said secondreduction construct comprising: a second locking limb; a secondcontractible loop; and a second opposed loop disposed generally oppositeto said second contractible loop, wherein reduction of said secondopposed loop contracts said second contractible loop.
 9. The suturesystem of claim 8, wherein said first and said second contractible loopsand said first and said second opposed loops are separated by a firstand a second loop defined by first and second knots, respectively. 10.The suture system of claim 9, wherein first portions of said first andsaid second opposed loops extend through said first and said secondloops from said first and said second contractible loops, respectively,and wherein second portions of said first and said second opposed loopsextend through said first and said second loops and terminate at saidfirst and said second locking limbs, respectively.
 11. The suture systemof claim 10, wherein first portions of said first and said secondcontractible loops extend through said first and said second loops fromsaid first and said second opposed loops, respectively, and whereinsecond portions of said first and said second contractible loops extendfrom and terminate at said first and said second knots, respectively.12. The suture system of claim 9, wherein said first and said secondlocking limbs are passed through said first and said second opposedloops, respectively.
 13. The suture system of claim 12, furthercomprising a second pusher tube defining a second lumen, wherein saidsecond pusher tube is advanced over portions of said second opposedloops, and wherein distal portions of said second opposed loop extendbeyond said second pusher tubes.
 14. The suture system of claim 8,further comprising a suture pin configured to be disposed through saidfirst and said second contractible loops.
 15. The suture system of claim8, further comprising a suture plate configured to be proximate to saidbridge, said suture plate including two apertures spaced apart from eachother a distance substantially equal to a length of said bridge.